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Anterior Knee Pain SyndromeflossingNCT06271811

Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome

A study testing Flossing band and Conventional physiotherapy in people with Anterior Knee Pain Syndrome and Patellofemoral Pain Syndrome, run by University of Jaén at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to assess the efficacy of adding flossing band therapy to conventional physiotherapy in patients diagnosed with Patellofemoral Pain Syndrome (PFPS). Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
Flossing band and Conventional physiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
9 Jan 2023to 20 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • A clinical diagnosis of Patellofemoral Pain Syndrome or patellofemoral misalignment, as confirmed by clinical signs and/or imaging studies (e.g., knee CT scans).
  • An age range of 18 to 50 years, to include a broad spectrum of the population affected by PFPS.
  • Experience retro patellar pain for at least three months, including pain at rest or during activities such as ascending or descending stairs, jumping, running, squatting, kneeling, or prolonged sitting.
  • Pain or apprehension upon mobilization of the patella, and/or crepitus accompanied by pain during activities like squats.
  • No history of medical treatment, physiotherapy specifically targeting PFPS, or lower extremity surgery within the last six months.

Who cannot join

  • A history of significant lower extremity, pelvic, or spinal surgery/fracture, or traumatic lesions of ligaments or meniscus within the past six months.
  • Presence of other orthopedic conditions (e.g., ligament rupture, meniscal tears), neurological disorders (e.g., multiple sclerosis, paralysis), rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis), or congenital conditions leading to osteoarthrosis.
  • Current pregnancy.
  • A history of connective tissue disease, patellofemoral dislocation or subluxation, or osteoarthrosis of the knees.
  • Use of sedatives or muscle relaxants that may alter muscle tone.
  • Other forms of anterior knee pain (e.g., Osgood-Schlatter disease, tendon pain, bursitis).
  • A history of referred pain from the lumbar spine.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of Jaen

    Jaén, 23009

Other trials in Spain

About this study

Official title: Evaluating the Impact of Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome

The goal of this clinical trial is to assess the efficacy of adding flossing band therapy to conventional physiotherapy in patients diagnosed with Patellofemoral Pain Syndrome (PFPS). The main questions it aims to answer are:

  • Does combining flossing band therapy with conventional physiotherapy lead to greater improvements in pain, strength, and function compared to conventional physiotherapy alone?
  • What are the effects of flossing band therapy on knee functionality and muscle strength in PFPS patients? Participants will be randomly assigned to either the Standard Physiotherapy group or the Flossing Band and Physiotherapy group. In addition to conventional physiotherapy, participants in the Flossing Band group will undergo sessions where a flossing band is applied around the knee joint to provide moderate compression. Researchers will compare the two groups to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS.
Read the detailed description

The goal of this clinical trial is to assess the efficacy of integrating flossing band therapy into conventional physiotherapy for individuals diagnosed with Patellofemoral Pain Syndrome (PFPS). A double-blinded, randomized controlled trial was conducted to evaluate the influence of adding flossing band application to conventional physiotherapy based on 8 weeks of resistance training in patients with PFPS. The study was approved by the research ethics committee of the University of Jaén and conducted in accordance with the Code of Ethics of the World Medical Association for human studies (Declaration of Helsinki). A sample of 50 participants diagnosed with PFPS were randomly allocated into two distinct groups: the Standard Physiotherapy Group (SPG) and the Flossing Band and Physiotherapy Group (FBPG). Eligibility criteria included a clinical diagnosis of PFPS, retro patellar pain for at least three months, and no recent medical treatment or lower extremity surgery within the last six months. Participants underwent assessments at baseline and after 8 weeks of rehabilitation protocols, including standardized measures of pain intensity, knee functionality, and overall mobility. The intervention protocols involved either conventional physiotherapy focused on neuromuscular training or a combined treatment regimen of conventional physiotherapy along with additional flossing band therapy targeting the knee region. Researchers applied rigorous blinding protocols to ensure impartial evaluations and minimize bias. Outcome measures included the Kujala Anterior Knee Pain Scale (AKPS), handheld dynamometry for knee extensor muscle strength, a visual analog scale (VAS) for pain assessment, and the Lower Extremity Functional Scale (LEFS) for self-reported function, isokinetic variables, including peak torque, total work, and average power, were assessed using the Biodex System 4 dynamometer and emotional and psychological variables. The study aimed to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS compared to conventional physiotherapy alone.

Being tested
Flossing band, Conventional physiotherapy
Keywords
Patellofemoral Pain Syndrome, physiotherapy, mind-body, flossing band
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flossing bandProcedure or surgery

    The application of flossing to the knee commences with a preliminary evaluation of the joint range of motion and pain perception. The band is wrapped around the knee, starting with an approximate tension of 50% for the first wrap and escalating to a tension of 60-80% in subsequent wraps. It\'s essential to overlap the band with each wrap, moving from a distal to the proximal direction (bottom to top), which aids in enhancing drainage. Continuous monitoring of the patient is critical to ensure that excessive pressure is not being applied. This can be achieved by palpating the pulse on the dorsum of the foot or inner ankle, and observing if the skin regains its normal color after pressing the area with fingers. Should the patient experience strong tingling or pain, the bandage must be immediately removed. The duration of the band's application varies between 2 to 5 minutes, depending on patient tolerance, a methodology informed by existing research.

  • Conventional physiotherapyOther

    The intervention protocol is centered on neuromuscular training, targeting the strengthening of key muscle groups including the quadriceps, hamstrings, and hip abductors, which are vital for knee stabilization. This approach is supported by previous research, emphasizing the importance of these muscle groups in knee joint health. Complementing this, proprioceptive exercises, such as single-leg balances and controlled knee bends, were incorporated to enhance joint position sense, aligning with the guidelines set forth by Powers et al., 2010.

    The intensity of these exercises is progressively increased, tailored to each patient's tolerance and improvement. The protocol stipulates two sessions per week over eight weeks.

Study groups in NCT06271811
Study groupRoleWhat they receive
Control groupActive comparatorThe intervention protocol is centered on neuromuscular training, targeting the strengthening of key muscle groups including the quadriceps, hamstrings, and hip abductors, which are vital for knee stabilization. This approach is supported by previous research, emphasizing the importance of these muscle groups in knee joint health. Complementing this, proprioceptive exercises, such as single-leg balances and controlled knee bends, were incorporated to enhance joint position sense, aligning with the guidelines set forth by Powers et al., 2010. The intensity of these exercises is progressively increased, tailored to each patient's tolerance and improvement. The protocol stipulates two sessions per week over eight weeks.
Receives: Other: Conventional physiotherapy
Intervention groupExperimentalThe application of flossing to the knee commences with a preliminary evaluation of the joint range of motion and pain perception. The band is wrapped around the knee, starting with an approximate tension of 50% for the first wrap and escalating to a tension of 60-80% in subsequent wraps. It is essential to overlap the band with each wrap, moving from a distal to the proximal direction (bottom to top), which aids in enhancing drainage. Continuous monitoring of the patient is critical to ensure that excessive pressure is not being applied. This can be achieved by palpating the pulse on the dorsum of the foot or inner ankle, and observing if the skin regains its normal color after pressing the area with fingers. Should the patient experience strong tingling or pain, the bandage must be immediately removed. The duration of the band's application varies between 2 to 5 minutes, depending on patient tolerance, a methodology informed by existing research.
Receives: Procedure: Flossing band

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disability related to patellofemoral pain

    The Kujala Anterior Knee Pain Scale was employed to assess this variable. is a well-established tool used to evaluate symptoms and functional limitations in individuals with patellofemoral pain syndrome. This self-reported questionnaire comprises 13 items, each rated to provide a total score ranging from 0 to 100, where higher scores denote better knee function and fewer symptoms. While specific cut-off points are not universally defined, scores closer to 100 generally indicate minimal patellofemoral issues.

    Measured: From baseline to 8 weeks

  2. Knee extensor muscle strength

    In addition to isokinetic variables assessed with the Biodex System 4 dynamometer, manual handheld dynamometry was employed to measure knee extensor muscle strength, providing a comprehensive evaluation of muscle function in individuals with Patellofemoral Pain Syndrome.

    Measured: From baseline to 8 weeks

  3. Pain report

    Pain was measured using a visual analogue scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate on the scale their current level of pain being higher values related to more intense pain.

    Measured: From baseline to 8 weeks

Secondary outcomes (6)
  1. Self-reported function

    Self-reported function: The lower limb function was assessed by the Lower Extremity Functional Scale (LEFS) is a valid and reliable instrument to determine the functional status of acute and chronic lower extremity musculoskeletal dysfunction. It is a 20-item questionnaire whose items are ranged in a five-point scale ranging from zero to four to assess the difficulty in performing different tasks due to physical dysfunction in the lower extremities. The final score of all the items is calculated on a 0-80 score scale, correlated with low and high functional levels respectively, and has been deemed to be a valid and reliable self-reported assessment tool

    Measured: From baseline to 8 weeks

  2. Short Form-36 (SF-36)

    The SF-36 is widely utilized as a comprehensive measure of health-related quality of life. It comprises 36 items categorized into eight domains: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role, and mental health. Additionally, it offers summary scores for the physical and mental components (PCS and MCS), with higher scores indicating better overall health-related quality of life.

    Measured: From baseline to 8 weeks

  3. Berg Balance Scale (BBS)

    This assessment tool is employed for balance evaluation. It comprises 14 items, each rated from 0 to 4, with the scores aggregated to yield a total score ranging from 0 to 56. A higher total score signifies improved balance. Scores between 0 and 20 indicate wheelchair mobility, 21 to 40 suggest walking with assistance, while a score of 41 to 56 indicates independent walking ability.

    Measured: From baseline to 8 weeks

  4. Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to assess sleep quality and disturbances over a one-month time interval. It evaluates seven components of sleep, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component is scored on a scale of 0 to 3, with higher scores indicating poorer sleep quality. The total score, which ranges from 0 to 21, is calculated by summing the scores of the seven components, with higher scores indicating worse overall sleep quality. The PSQI is widely used in both clinical and research settings to evaluate sleep patterns and disturbances.

    Measured: From baseline to 8 weeks

  5. Brief Pain Questionnaire

    The Brief Pain Inventory (BPI) is a widely used self-report questionnaire designed to assess the severity of pain and its impact on various aspects of daily functioning. It consists of two main sections: the Pain Severity Scale and the Pain Interference Scale. The Pain Severity Scale assesses the intensity of pain at its "worst," "least," "average," and "right now" over the past week, rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). The Pain Interference Scale evaluates the degree to which pain interferes with various domains of daily life, such as general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Responses are also rated on a scale from 0 (does not interfere) to 10 (completely interferes).

    Measured: From baseline to 8 weeks

  6. Perceived Stress Scale

    The Perceived Stress Scale (PSS) is a self-report questionnaire designed to measure the perception of stress in individuals over the past month. It consists of 10 items that assess the degree to which situations in one's life are appraised as stressful. Respondents rate the frequency of their feelings and thoughts related to stress on a scale from 0 (never) to 4 (very often). The items cover various aspects of stress, including feelings of unpredictability, lack of control, and overwhelm. The scores for each item are summed to obtain a total score, with higher scores indicating higher levels of perceived stress.

    Measured: From baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start9 Jan 2023
  3. Primary completion14 Nov 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06271811
Sponsor's protocol ID
UJAPFPS
Acronym
flossing
Status last verified
Feb 2024
First submitted
14 Feb 2024
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Flossing band and Conventional physiotherapy in people with Anterior Knee Pain Syndrome and Patellofemoral Pain Syndrome, run by University of Jaén at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability related to patellofemoral pain (time frame: From baseline to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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